A Phase 1 Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)

• Status: Recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: All

Summary

• To evaluate the safety and tolerability of escalating doses of ERAS-801 in study participants with recurrent glioblastoma multiforme (GBM).

• To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-801.

• To evaluate the antitumor activity of ERAS-801.

• To evaluate the PK profile of ERAS-801.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasca, Inc.

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Willing and able to give written informed consent

• Diagnosis of Glioblastoma, IDH WT as defined by the WHO 2021 criteria

• Adequate organ function

• Willing to comply with all protocol-required visits, assessments, and procedures

• Able to swallow oral medication

Exclusion Criteria:

• Prior treatment with an EGFR inhibitor for Glioblastoma

• Currently enrolled in another therapeutic study

• History of clinically significant cardiovascular disease

• Gastrointestinal conditions that may affect administration/absorption of oral medications

• Have an active infection (bacterial, fungal, or viral) requiring systemic therapy

• Pregnant or breastfeeding women

• Any serious underlying medical or psychiatric condition or evidence of any other significant clinical disorder or laboratory finding that renders the patient inappropriate to participate in the study

• Known allergies, hypersensitivity, or intolerance to ERAS-801 or its excipients